Can Rhodiola Crenulata Intake Improve Oxygen Saturation and Decrease the Incidence of Acute Mountain Sickness.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Incidence measured by Lake Louise acute mountain sickness score (LLS) ≥ 3 with headache and one other symptom.
研究概览
简要总结
Traditional folk medicine in the Arctic and Himalayan areas used Rhodiola species to enhance physical endurance, prevent aging, resist acute mountain sickness (AMS), and to treat fatigue, depression, anemia, impotence and respiratory infections. Rhodiola crenulata are widely used to prevent AMS in Himalayan areas and Lhasa in Tibet but none was examined by human study. The investigators conducted a randomized, double blind, placebo controlled, crossover study to investigate the efficacy of Rhodiola crenulata in preventing AMS.
详细描述
The number of people traveling to altitude for work or for recreation is rising, and increased media attention towards these activities has also raised the profile of altitude related illness. The most effective preventive measure for acute mountain sickness (AMS)-gradual ascent-is frequently difficult or impractical for modern international travel to locations such as Lhasa in Tibet (3650 m) and La Paz in Bolivia (3740 m). In order to solve this problem, prophylactic acetazolamide was most commonly used. But prescription needed and side effects such as paresthesia and nausea are the disadvantage of using acetazolamide. Some over-the-counter herbal supplements with essentially no adverse effect were widely used, such as Rhodiola species. Rhodiola crenulata are widely used to prevent AMS in Himalayan areas and Lhasa in Tibet but none was examined by human study. The investigators conducted a randomized, double blind, placebo controlled, crossover study to investigate the efficacy of Rhodiola crenulata in preventing AMS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 20 and 55 years.
- •able to complete the study protocol of 9-day study regimens and mountain climbing twice.
- •no prophylactic medication or herb one month before ascent.
- •maintaining the same living conditions and habits four months before the first mountain climbing and four months between two mountaineering.
- •living in the same altitude or within a difference of 200 meters.
- •no additional physical training.
- •no plan to gain or loss weight.
- •no altitude exposure above 2500m.
排除标准
- •any history of chronic obstructive pulmonary disease, heart failure, cerebral neoplasm, mania, renal or hepatic insufficiency.
- •women in pregnancy or intending of pregnancy during the 4-month study period.
研究组 & 干预措施
Rhodiola crenulata-placebo sequence
Rhodiola crenulata for the first treatment period and placebo for the second treatment period, with a washout period of 4 months. Overall study population were 120 subjects, who were randomised and allocated into 2 sequences.
干预措施: Rhodiola crenulata (Drug)
Rhodiola crenulata-placebo sequence
Rhodiola crenulata for the first treatment period and placebo for the second treatment period, with a washout period of 4 months. Overall study population were 120 subjects, who were randomised and allocated into 2 sequences.
干预措施: placebo (Drug)
Placebo-Rhodiola crenulata sequence
Placebo for the first treatment period and Rhodiola crenulata for the second treatment period, with a washout period of 4 months. Overall study population were 120 subjects, who were randomised and allocated into 2 sequences.
干预措施: Rhodiola crenulata (Drug)
Placebo-Rhodiola crenulata sequence
Placebo for the first treatment period and Rhodiola crenulata for the second treatment period, with a washout period of 4 months. Overall study population were 120 subjects, who were randomised and allocated into 2 sequences.
干预措施: placebo (Drug)
结局指标
主要结局
Incidence measured by Lake Louise acute mountain sickness score (LLS) ≥ 3 with headache and one other symptom.
时间窗: within 18 hours after ascent to altitude 3100m
The LLS rates 5 symptoms (headache, gastrointestinal symptoms such as nausea and vomiting, fatigue and/or weakness, dizziness and/or light-headedness, and difficulty sleeping), with each item graded on a scale from 0 to 3. A score of 3 points or greater constitutes AMS.
次要结局
- blood oxygen content(on arrival of altitude 3100m)
- severe AMS(within 18 hours after ascent to altitude 3100m)
- severity of headache, incidence of headache and severe headache(Within 18 hours after ascent to altitude 3100m)